Australia-based companies are recalling hundreds of thousands of coronavirus tests after discovering that some Ellume COVID-19 home tests give higher-than-expected false-positive results.
Ellume became the first company to obtain approval from the Food and Drug Administration to sell consumer kits at major retailers such as Wal-Mart, CVS, Target and Amazon. The kit does not require a prescription and provides results in minutes.
However, the company found false-positive results at a higher rate than the company’s original clinical studies showed, “identifying the cause and confirming that the incidence of this false-positive is limited to a particular lot. Did”.
The company recalled 43 lots shipped to retailers, distributors and the Pentagon from April to August. You can check the lot number of the test carton and see if it is in the recalled lot listed at www.ellumecovidtest.com / return. Alternatively, you can call 1-888-807-1501 Monday through Friday from 9 am to 5 pm Eastern Standard Time.
Ellume said affected customers will be notified through the Ellume COVID-19 home test app. Within two weeks, the company will send an email to consumers who test positive for the recalled product.
more:FDA approves COVID-19 home test from ACON Laboratories, potentially doubling national supply
Consumers who did not take the second confirmation test after being tested positive by the recalled Elm test should be aware that the test results may have been incorrect, the company said. Ellume also said that customers who test positive using the recalled test kit should not be assumed to be unaffected by COVID.
In a statement, Ellume CEO Sean Parsons apologized to customers who experienced “stress or difficulty” from false positives.
“You have my personal commitment that we have learned from this experience, we have implemented additional controls, we are working on solving the issues that led to this recall, And we will do our best to regain your trust, “Parsons said.
USA TODAY reported last month that several consumers who purchased the Ellume test complained about false-positive results when compared to laboratory-based PCR tests. Some consumers have complained about false positive results on CVS and Amazon’s customer feedback portal.
“Trying to catch all cases”:Do Cheap Home Coronaviruses Test Delta Antidotes?
April:Prescription-free rapid COVID-19 home test for sale in CVS, Walgreens and Wal-Mart starting this week
Last month, Parsons admitted that some customers had false-positive results and said the test was adjusted to detect more cases than other rapid antigen tests. At the time, Parsons said the company was discussing the possibility of “updating the testing decision-making process” with federal regulators and “hoping on their blessings to roll it out in the future.” Told.
Ellume said the false-positive test rates for the recalled lots were higher than those shown by the company’s clinical research data submitted to the FDA.
Ellume identified a total of 427,000 tests from the recalled lots. Approximately 195,000 are unused and can be replaced with new tests as part of the recall. About 42,000 gave positive results. Ellume does not say what percentage was false positives.
In clinical trials, when used in symptomatic individuals, Ellume correctly identified 96% of positive samples and 100% of virus-free samples when compared to lab-based PCR tests. Ellume’s accuracy numbers were reduced when used by asymptomatic individuals. 91% of positive samples and 96% of negative samples were correctly identified.
Ken Alltucker is published on Twitter as @kalltucker or can be emailed to firstname.lastname@example.org.
False positives are due to recalls
Source link False positives are due to recalls